CMC Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d7lzj

Location: Italy (Hybrid working options available)

Possiede le competenze e l'esperienza giuste per questo ruolo? Continui a leggere per scoprirlo e invii la sua candidatura.
Salary Range: €60,000 – €110,000 (dependent on experience)

About the Opportunity
We are supporting a growing, innovative biotechnology company developing next-generation therapies within a specialist therapeutic area. As the company continues to advance its pipeline through clinical development, they are seeking an experienced CMC Manager to lead Chemistry, Manufacturing and Controls activities across their development programmes.

This is an exciting opportunity for a CMC professional who enjoys working in a dynamic biotech environment, combining strategic oversight with hands‑on management of external development and manufacturing activities. The successful candidate will play a key role in ensuring the successful progression of assets from development through clinical supply and regulatory milestones.

Position Summary




The CMC Manager will be responsible for overseeing CMC activities related to pharmaceutical development, manufacturing, and regulatory support. This role will provide technical leadership across analytical development, formulation, process development, and external manufacturing activities, ensuring delivery of high-quality drug substances and drug products in line with regulatory expectations.

Working closely with internal cross‑functional teams and external partners, the CMC Manager will support the development strategy of clinical‑stage programmes while ensuring compliance with global regulatory requirements, including FDA and EMA guidelines.

Key Responsibilities

-
- Lead and coordinate CMC activities supporting pharmaceutical development and clinical programmes, including:
- Drug substance and drug product manufacturing
- Stability programmes and lifecycle activities
- Manage relationships with external CDMO/CMO partners, ensuring timely delivery of high‑quality mater

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d7lzj